Genmab(GMAB)2024-05-02 22:05Financial Data and Key Metrics Changes - Total revenue for Q1 2024 reached over DKK 4.1 billion, representing a 46% year-over-year increase [47] - Recurring revenue grew by 42% in Q1, driven by strong royalties from DARZALEX, KESIMPTA, and other approved medicines, as well as net product sales for EPKINLY [45][22] - Operating profit exceeded DKK 800 million, up more than 90% compared to the previous year [47] Business Line Data and Key Metrics Changes - DARZALEX net sales were just under US637 million in Q1, marking a 66% year-over-year growth [16] - EPKINLY generated US27 million in net sales for Q1, marking the 10th consecutive quarter of demand growth [42] Market Data and Key Metrics Changes - DARZALEX's new patient share in frontline therapy is now 53%, showing over 14% absolute growth compared to the same time last year [91] - KESIMPTA continues to lead in new-to-brand share in seven of the ten major markets outside the U.S. [16] Company Strategy and Development Direction - The proposed acquisition of ProfoundBio is expected to enhance the company's mid to late-stage clinical pipeline and strengthen capabilities in the ADC space [30] - The company anticipates strong revenue growth of 19% for 2024, driven by royalty medicines and significant contributions from EPKINLY and Tivdak [24] - The focus remains on oncology, with plans to prioritize opportunities in this area while also exploring immunology and inflammation [78] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential of EPKINLY and Tivdak, which are expected to drive nearly 40% of total revenue growth in 2024 [24] - The company is committed to investing in R&D to support the advancement of its clinical programs, particularly for EPKINLY and Tivdak [49] - Management highlighted the importance of regulatory approvals and successful launches for future growth [45] Other Important Information - The FDA granted priority review for EPKINLY as a treatment for relapsed or refractory follicular lymphoma, with a PDUFA date of June 28 [9] - The company plans to update overall guidance no later than the second quarter 2024 earnings [58] Q&A Session Summary Question: Insights on recent FDA MRD negativity in first-line myeloma - Management noted that MRD negativity is beneficial for patients and allows for the development of novel mechanisms in frontline therapy [67] Question: Updates on GEN1046 and ASCO data - Management confirmed that they are operationalizing towards activating the study by the end of the year and emphasized the importance of overall survival as a key endpoint [68] Question: Thoughts on business development priorities - The focus remains on oncology, particularly the ProfoundBio acquisition, while also considering opportunities in immunology [78] Question: Competitive landscape for DARZALEX - Management indicated that while there are new competitors, DARZALEX has established a strong presence in earlier lines of therapy [116] Question: EPKINLY's market penetration and community adoption - Management reported a modest shift towards community practices, with ongoing efforts to expand usage beyond major academic centers [140]